•     By Jason Derry —

    Genentech
    Genentech and AC Immune have announced a $300 million licensing agreement relating to the development of antibodies
    for treating Alzheimer's disease.  AC
    Immune's research in the Alzheimer's area includes inducing anti-beta amyloid
    antibody production in patients.  The
    announcement marks the third recent major licensing deal between Genentech and
    a
    partner whose research focuses on a particular therapeutic area, including an
    October deal with CGI Pharmaceuticals ($500 million deal relating to cancer and immune diseases) and a July deal with
    Inotek Pharmaceuticals ($405 million deal relating to cancer treatment).

    AC Immune
    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.

  •     By Jason Derry —

    Targeted Genetics
    Targeted Genetics Corp. has announced a non-exclusive licensing deal with Amsterdam Molecular Therapeutics B.V. relating to the use of the AAV1 (Adeno-Associated Virus
    Type 1) vector.  The licensed AAV1 vector
    is covered by U.S. Patent Nos. 6,759,237 and 7,105,345.  AMT intends to use the vector for developing
    therapeutics for treating type I and type V lipoprotein lipase (LPL) deficiency.  In particular, AMT will use
    the vector in the development of its lead gene product, AMT-011, which is in
    Phase II clinical trials.  AMT and
    Targeted Genetics are both focused on developing gene therapies for a variety
    of diseases.

    Amsterdam Molecular Therapeutics
    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.

  •     By Christopher P. Singer

    USPTO Seal - background
    The U.S. Patent and Trademark Office will be releasing an
    updated version of private PAIR (Patent Application Information Retrieval),
    which allows registered practitioners access to information regarding their
    patent applications electronically. To
    announce the launch, the USPTO will be holding a webinar on Tuesday, December
    19, 2006 at 1:00 pm (Eastern). If you
    are a PAIR user, or are considering using PAIR, you can sign up for this 90
    minute broadcast here.

    Some of the new features include: Customer Number Details Online
    Self-Administration, Attorney Docket Number Online Self-Administration, Pending
    Non-Published PCT Application Search, Ordering of Certified Copies for Private
    Applications via Private PAIR, XML Application Data Download, and a Display
    References Tab that will have two more sections of references.

  •     By Donald Zuhn

    In an
    appeal from a District Court decision granting a preliminary injunction in
    favor of Plaintiffs-Appellees Sanofi-Synthelabo, Sanofi-Synthelabo, Inc., and
    Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership (Sanofi), the
    Federal Circuit concluded that the District Court did not abuse its discretion
    in granting preliminary injunctive relief, and thus, affirmed the District
    Court's grant of the preliminary injunction.

    Claimed_genus_1
    Sanofi owns U.S. Patent No. 4,847,265 (the
    '265 patent), which relates to clopidogrel bisulfate, the active ingredient in
    Plavix®, a platelet aggregation inhibiting agent marketed by Sanofi for use
    in reducing thrombotic events such as heart attacks and strokes.  Clopidogrel is the dextrorotatory enantiomer
    (d-enantiomer) of the free base methyl
    alpha-5-(4,5,6,7-tetrahydro(3,2-c)thienopyridyl)-(2-chlorophenyl) acetate
    (MATTPCA).

    Apotex #1
    Seeking
    approval to market generic clopidogrel bisulfate, Defendants-Appellants Apotex,
    Inc. and Apotex Corp. (Apotex) filed an Abbreviated New Drug Application (ANDA)
    with the FDA.  In response, Sanofi filed
    suit against Apotex, alleging that the filing of the ANDA infringed the '265
    patent.  Apotex counterclaimed asserting
    that the '265 patent was invalid and unenforceable.  Shortly before the FDA approved Apotex's
    ANDA, the parties began settlement negotiations.  However, after failing to receive regulatory
    approval for either of two settlement agreements, Apotex launched its generic
    clopidogrel bisulfate product.  In
    response, Sanofi filed a motion for a preliminary injunction.

    Sanofi-Aventis_large
    Following
    an evidentiary hearing, the District Court granted Sanofi's motion for
    injunctive relief, finding that Apotex failed to establish a likelihood of
    proving invalidity at trial.  In
    particular, the District Court rejected Apotex's anticipation, obviousness, and
    obviousness-type double patenting defenses, and determined that Apotex failed
    to raise a substantial question with regard to the enforceability of the '265
    patent.  Apotex then appealed the
    District Court's grant of the preliminary injunction.

    With regard
    to its anticipation defense, Apotex argued on appeal that because a skilled
    artisan would interpret claim 2 of U.S. Patent No. 4,529,596 (the '596 patent)
    as disclosing not only the racemate free base of clopidogrel, but also its
    dextrorotatory and levorotatory enantiomers and pharmaceutically acceptable
    salts, the '596 patent anticipated the '265 patent.  Apotex also argued that the holdings in In re
    May
    , 574 F.2d 1082 (C.C.P.A. 1978), In re Petering, 301 F.2d 676 (C.C.P.A.
    1962), and In re Schaumann, 572 F.2d 312 (C.C.P.A. 1978) mandated a finding of
    anticipation in the instant case.

    Finding
    that the '596 patent discloses only the free base of clopidogrel, and does not
    expressly describe the dextrorotatory and levorotatory enantiomers or any salt,
    the Federal Circuit determined that the '596 patent fails to describe each and
    every limitation of claim 3 of the '265 patent.  The Federal Circuit also rejected Apotex's argument that the '596 patent
    inherently discloses the bisulfate salt of clopidogrel, determining that the
    District Court did not clearly err in finding that a skilled artisan reading
    the '596 patent would believe that the hydrochloride salt, rather than the
    bisulfate salt, was the preferred salt of clopidogrel.

    The Federal
    Circuit also found that the facts in the instant case could be distinguished
    from those in May, Petering, and Schaumann.  In contrast with May, the Federal Circuit noted that in the instant
    case, the '596 patent contained no clear statement that the bisulfate salt is
    "especially suitable" for administering compounds of the genus
    including clopidogrel.  Unlike in Petering,
    where "specific preferences" in an anticipatory reference were found
    to narrow a broad generic formula to a more limited class of twenty compounds,
    the Federal Circuit determined that no such "pattern of preferences"
    could be found in the '596 patent that limited the broad generic formula to a
    limited class including clopidogrel bisulfate.  Finding no error in the District Court's determination that the '596
    patent does not inherently disclose clopidogrel bisulfate or its determination
    that clopidogrel bisulfate is not a species of the genus disclosed in the '596
    patent, the Federal Circuit concluded that the District Court did not clearly
    err in finding that Apotex's anticipation defense lacked substantial merit.

    With regard
    to its obviousness defense, Apotex argued on appeal that it would have been
    obvious to one of ordinary skill in the art to prepare clopidogrel bisulfate
    based on the disclosure of the '596 patent.  Apotex also argued that the unexpected results upon which Sanofi relied
    to establish clopidogrel bisulfate's nonobviousness would not have been
    unexpected to a skilled artisan.  Apotex
    further argued that the District Court erred by failing to consider In re
    Adamson
    , 275 F.2d 952 (C.C.P.A. 1960), in its obviousness analysis.

    Noting that a party alleging invalidity due
    to obviousness cannot "merely identify each element in the prior art to
    establish unpatentability of the combined subject matter as a whole," but
    rather, "must articulate the reasons one of ordinary skill in the art
    would have been motivated to select the references and to combine them to
    render the claimed invention obvious," the Federal Circuit concluded that
    "nothing [in the '596 patent] directed a chemist to the particular
    enantiomer and salt, clopidogrel bisulfate, which is the limited subject matter
    of claim 3 [of the '265 patent]."  The Federal Circuit also concluded that the District Court had not
    clearly erred in evaluating the evidence relating to the unexpected results
    obtained with clopidogrel bisulfate.  Finally, the Federal Circuit determined that the instant case could be
    distinguished from Adamson since the '596 patent does not disclose the
    bisulfate salt of the d-enantiomer of MATTPCA, resolution of MATTPCA would not
    yield the unnamed bisulfate salt, and it was unexpected that the desirable
    activity of clopidogrel would be found only in the d-enantiomer.  The Federal Circuit, therefore, concluded
    that the District Court did not clearly err in finding that Apotex failed to
    raise a substantial question in its obviousness defense.

    Sanofi-Synthelabo v. Apotex, Inc. (Fed. Cir. 2006)
    Panel: Circuit Judge Lourie, Senior Circuit Judge Clevenger, and Circuit Judge Bryson
    Opinion by Circuit Judge Lourie
  •     By Sherri Oslick

    Gavel
    About Court Report: Each week we will report briefly
    on recently filed biotech and pharma patent cases.  A few interesting cases will be selected for
    periodic monitoring, providing our readers with an opportunity to follow the
    progress of these cases.

    Stephen J. Smith Trust et. al. v. Ethicon, Inc.
    1:06-cv-02371; filed November 27, 2006 in the District
    Court of Colorado

    Infringement of U.S. Patent No. 6,482,431 ("Method
    for Application and Maintenance of Medication on Body Tissue," issued
    November 19, 2002) based on Ethicon's (a subsidiary of Johnson & Johnson)
    marketing and sale of its Dermabond® brand topical skin adhesive.  View the complaint here.


    Eli Lilly and Company v. Sun Pharmaceutical Industries
    Ltd.

    1:06-cv-01721; filed December 1, 2006 in the Southern
    District of Indiana

    Infringement of U.S. Patent No. 5,464,826 ("Method
    of Treating Tumors in Mammals with 2',2'-difluoronucleosides," issued
    November 7, 1995) following a paragraph IV certification as part of Sun
    Pharmaceutical's filing of an ANDA to manufacture a generic version of Lilly's
    Gemzar® (gemcitabine hydrochloride for injection, used to treat non-small
    cell lung cancer, pancreatic cancer, breast cancer, and ovarian cancer).  Also, declaratory judgment of validity,
    enforceability, and infringement of the '826 patent.  View the complaint here.


    Savient Pharmaceuticals, Inc. v. Sandoz, Inc. and
    Upsher-Smith Laboratories, Inc.

    2:06-cv-05782; filed December 4, 2006 in the District
    Court of New Jersey

    Infringement of U.S. Patent Nos. 5,872,147 ("Use of
    Oxandrolone in the Treatment of Chronic Obstructive Pulmonary Disease,"
    issued February 16, 1999), 6,090,799 ("Method for Ameliorating Muscle
    Weakness/Wasting in a Patient Infected with Human Immunodeficiency Virus-Type
    1," issued July 18, 2000), 6,670,351 (same title, issued December 30,
    2003), 6,576,659 ("Use of Oxandrolone in the Treatment of Burns and Other
    Wounds," issued June 10, 2003), and 6,828,313 (same title, issued December
    22, 2004) based on Sandoz's manufacture and sale of generic Oxandrin®
    (oxandrolone) for uses claimed in the asserted patents.  Savient also filed for a temporary
    restraining order and a preliminary injunction; the temporary restraints were
    granted and subsequently vacated, with permission granted to the parties to
    file an interlocutory appeal on the issue.  View the complaint here.


    Merck & Co., Inc. v. Apotex, Inc. et. al.

    3:06-cv-05789; filed December 4, 2006 in the District
    Court of New Jersey

    Infringement of U.S. Patent No. 4,797,413 ("Thieno
    Thiopyran Sulfonamide Derivatives, Pharmaceutical Compositions and Use,"
    issued January 10, 1989) following a paragraph IV certification as part of
    Apotex's filing of an ANDA to manufacture a generic version of Merck's
    Trusopt® (dorzolamide hydrochloride ophthalmic solution, used to treat
    elevated intraocular pressure in patients with ocular hypertension or
    open-angle glaucoma).  View the complaint here.


    Merck & Co., Inc. v. Apotex, Inc. et. al.

    3:06-cv-05791; filed December 4, 2006 in the District
    Court of New Jersey

    Infringement of U.S. Patent No. 4,797,413 ("Thieno
    Thiopyran Sulfonamide Derivatives, Pharmaceutical Compositions and Use,"
    issued January 10, 1989) following a paragraph IV certification as part of
    Apotex's filing of an ANDA to manufacture a generic version of Merck's
    Cosopt® (dorzolamide hydrochloride/timolol maleate ophthalmic solution, used
    to treat elevated intraocular pressure in patients with ocular hypertension or
    open-angle glaucoma).  View the complaint here.


    Dusa Pharmaceuticals, Inc., et. al. v. Photo
    Therapeutics, Ltd. et. al.

    2:06-cv-01017; filed December 4, 2006 in the Southern
    District of Ohio

    Infringement of U.S. Patent Nos. 6,710,066
    ("Photochemotherapeutic Method Using 5-aminolevulinic acid and Other Precursors
    of Endogenous Porphyrins," issued March 23, 2004) and 5,955,490 (same
    title, issued September 21, 1999) based on Photo Therapeutics publications
    providing instructions for photodynamic treatments of actinic keratosis using
    of aminolevulinic acid (the active incredient in Dusa's Levulan®).  View the complaint here.


    Celgene Corp., Novartis Pharmaceutical Corp. et. al. v.
    Abrika Pharmaceuticals Inc. et. al.

    2:06-cv-05818; filed December 4, 2006 in the District
    Court of New Jersey

    Infringement of U.S. Patent Nos. 5,837,284
    ("Delivery of Multiple Doses of Medications," issued November 17,
    1998) and 6,635,284 (same title, issued October 21, 2003) (both assigned to
    Celgene and licensed exclusively to Novartis in certain fields of use) following
    a paragraph IV certification as part of Abrika's filing of an ANDA to
    manufacture a generic version of Novartis' Ritalin® LA (methylphenidate
    hydrochloride extended release capsules, used to treat attention deficit
    hyperactivity disorder/attention deficit disorder).  View the complaint here.


    Celgene Corp., Novartis Pharmaceutical Corp. et. al. v.
    Abrika Pharmaceuticals Inc. et. al.

    1:06-cv-00741; filed December 6, 2006 in the District
    Court of Delaware

    Infringement of U.S. Patent Nos. 5,837,284 ("Delivery
    of Multiple Doses of Medications," issued November 17, 1998) and
    6,635,284 (same title, issued October 21, 2003) (both assigned to Celgene and
    licensed exclusively to Novartis in certain fields of use) following a
    paragraph IV certification as part of Abrika's filing of an ANDA to manufacture
    a generic version of Novartis' Ritalin® LA (methylphenidate hydrochloride
    extended release capsules, used to treat attention deficit hyperactivity
    disorder/attention deficit disorder).  View the complaint here.

  •     By Jason Derry —

    Milken Institute
    The Milken Institute,
    an independent think tank, has released a report that proposes a strategy that 
    may stimulate increased funding efforts for
    early-stage biotech research.  The
    strategy essentially involves public-private partnerships.

    The need to stimulate funding efforts for biomedical
    research stems from decreased or stagnant public funding, and from the tendency
    for companies to focus on potential big money discoveries.  For example, the Institute reports that
    investment in health care tends to be devoted to discovering and developing
    drugs that relate to "lifestyle" and "Western" diseases,
    because such drugs are the most profitable.  The consequence of this practice translates into a lack of proper
    funding for research relating to many deadly diseases, especially those that
    heavily affect third world countries.  In
    addition, up to 70% of marketed drugs do not generate enough money to cover
    their R&D costs.  Therefore, there is
    little financial incentive to fund research with a low likelihood of producing
    a high profit.  To address these
    problems, the report makes six recommendations, including:

    1.  Reduce risk by pooling intellectual property;
    2.  Use foundation funds to enhance credit quality and
    attract potential investors;
    3.  Use liability insurance to enhance credit quality;
    4.  Tap into the emerging market for IP-backed securities;
    5.  Use advanced purchases to underwrite medical research
    and drug delivery; and
    6.  Use donor bonds to underwrite medical research and
    drug delivery to under-funded patient groups.

    Each of these recommendations is discussed in more detail in Drug
    Discovery & Development
    .

    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.

  •     By Donald Zuhn

    Federal Circuit Seal
    In response to the adoption of Federal Rule of Appellate
    Procedure 32.1, the Federal Circuit has adopted new Federal Circuit Rule
    32.1
    .  Under the new Rule, parties will
    no longer be prohibited or restricted from citing nonprecedential dispositions
    issued by the Federal Circuit after January 1, 2007.  The new Rule supersedes Federal Circuit Rule
    47.6, which prohibited the citation of nonprecedential dispositions.  Under new Rule 32.1, the Federal Circuit may
    look to nonprecedential dispositions for guidance or persuasive reasoning, but
    will not give nonprecedential dispositions the effect of binding
    precedent.  In addition, the Federal
    Circuit will not consider nonprecedential dispositions of another court as
    binding precedent of that court unless the rules of that court so provide.  In view of new Federal Circuit Rule 32.1,
    beginning January 1st, Patent Docs will provide summaries of
    precedential and nonprecedential dispositions of the Federal Circuit that
    involve interesting issues of biotech or pharma patent law.

  •     By Kevin Noonan

    Once again, the popular press, aided and abetted by
    academics more interested in career advancement than the facts, have sounded
    the clarion call against patenting genes (see "Gene Patenting in the News Again").  For anyone interested in a reasoned debate on an important topic, the
    resulting articles are disheartening.  For those interested in advancing progress and U.S. economic interests,
    they are infuriating.

    Parade Magazine
    The latest jeremiad comes courtesy of Parade magazine, a
    popular component of Sunday section in many local newspapers.  It is helpful at the start to set out (and
    refute) the many factual misstatements in the article:

    • "A fifth of your genes belong to someone
    else."  Besides being contrary to the 13th amendment
    (banning having a property right in a person), no patent in the U.S. (or anywhere
    else) claims ownership of "your" genes.  All U.S. patents require that compositions of
    matter comprising "genes" are "isolated and purified."  So no one is going to knock on your door and
    ask for a royalty for using your genes.

    • "No one should own a disease" — and
    no one does.  There have been patents on
    isolated microorganisms, but this is not new: Louis Pasteur had patents on yeasts useful for wine and beer-making, and
    before the genetics revolution of the last half century, the only way to make
    useful antibiotics was to isolate the microorganism that happened to make the
    drug.

    • "Countries where they haven't patented genes have
    better genetic testing."  Correction: cheaper genetic testing, not better.  Where did the genetic test come from?  Not France, because they can't protect their genetic inventions in
    France.  The U.S. leads the world in
    biotechnology and is responsible for most of the "better genetic testing"
    that now exists.  There are many reasons
    why, but one important reason is that the companies that have developed those
    tests could get the economic support needed to take a scientific discovery and
    turn it into a useful test.  This is so
    because of patent protection.  If France
    can offer a cheaper test, it's because the French government permits companies
    in France to use technology without paying for it.  This is a good deal only if someone else is
    paying for it; Dr. Andrews' comments are
    a little like parents who don't get their children vaccinated, and then benefit
    from the vaccination of all the other kids in the neighborhood.

    • "Researchers are claiming they don't have to
    report deaths from genetic studies, calling them 'trade secrets'" and "[s]ome companies are willing to put
    people at risk to have an advantage."  Unlikely to be true.  But even if
    it is, human testing is not within the purview of the patent system.  The Food and Drug Administration controls
    clinical trials, and human testing in a university setting is governed by
    several levels of review boards enforced by Federal granting agency
    oversight.  The University of Illinois
    hospitals lost all Federal funding several years ago because they hadn't
    maintained proper records (i.e., paperwork); it is irresponsible to imply that people are dying without any evidence
    that it is so.

    • "You don't even have control over your own tissue
    or blood once it's donated for research."  The falsity of this statement is evidenced in the very next line of the
    article: "What can the public do?  Read consent forms at the hospital and doctor's office, and specify that you
    don't want your blood or tissue used for patented genetic research."  If you don't want your DNA to be used to
    fight diseases, by all means refuse to consent.  But then don't complain that your particular illness is an "orphan"
    that no one is interested in.

    • "Gene patenting is like someone owning the
    alphabet and charging you each time you speak."  In reality, since gene patents are all
    limited to isolated and purified DNA, the information contained in DNA is
    freely available.  No gene patent owner
    can "charge" you for using the genetic sequence — which is the key to the scientific information contained in your genes
    — in any way you wish.  Paradoxically, the economic interest and
    value produced in permitting companies to protect their investment in genetic
    technology has had the consequence of producing the greatest increase in
    biological knowledge in history.  The
    information generated on genes from humans, primates, mice, dogs, cats, horses,
    cows, pigs and many other species, including both useful and harmful
    microorganisms, is provided without charge to any researcher, capitalist or
    homemaker having and interest and a computer.  It is the equivalent of having publicly-accessible the blueprints of
    every machine ever made.

    Gene
    The problem with the misinformation contained in these
    articles is that they ignore important limitations imposed by the patent
    system.  As mentioned, individuals cannot
    be patented.  Human "body
    parts" can't be, either, just like it is illegal to sell a kidney.  (Ironically, in one of Dr. Andrews' books she
    advocates people having a property right in their DNA.  By that thinking, there is no legal
    justification to prevent an individual from deciding to sell a kidney, since it
    is his or her "property.")  No
    one owns your genes, or anyone else's.

    Moreover, the patent right is finite — it
    expires.  That's one of the beauties of
    the patent system, since it is a limited right, and one of those limitations is
    time.  Presently, a U.S. patent expires
    20 years from its earliest filing date.  For many of the earliest gene patents, that day is or soon will be
    here.  For the vast majority of gene
    patents, expiration will occur by 2020.  The biological reality is that, given the immense number of new genes
    identified (and still being identified), and publication of the genetic
    sequences of these genes in databases around the world, patent protection will
    expire before we have determined the usefulness of most of human genes.

    Just as in the generic drug debate, there is a balance to
    be struck between rewarding companies and universities that expend vast amounts
    of money, time and resources in discovering the genetic information necessary
    to produce a genetic test, and the cost of those tests to the public.  The answer is not to declare the underlying
    technology off-limits to patent protection.  That way leads to a real "tragedy of the commons" where no one
    has the economic incentive to develop a test that can be stolen by a competitor
    without compensation.  There are many
    ways to make testing available to those who cannot afford it; for those who can afford to pay, objections
    to paying for such testing is a fancy variant of "free-riding" on the
    time, efforts and accomplishments of others.  (At least those Americans looking for cheaper genetic testing in France
    can afford to support the airline industry in going there.)

    There are many facets to the legal implications of the
    revolution in genetics, including many included in the "Genetics Bill of
    Rights."  It does a disservice to
    the civil libertarian aspects of the debate — freedom from discrimination,
    freedom from prosecution, privacy rights over having yourself or your tissues
    used in research — to conflate them with gene patenting.  It is even more of a disservice to reasoned
    debate on the topic to misstate the issues to make political or rhetorical
    points, particularly when those misstatements are willful rather than
    misinformed.  Gene patenting is not a
    scourge and does not impose undue burdens on the public.  In fact, it is an important contributor to
    results desired by all: better
    technology to provide better prevention and treatment for human diseases.  It is a shame that some will obscure the
    facts to sell books or make headlines.

  •     By Christopher P. Singer

    American Stock Exchange
    I am always impressed by the variety of investment
    vehicles and innovative methods that investors and businesses use to
    generate money.  Back on October 25, 2006,
    Ocean Tomo, an intellectual capital merchant banc that specializes in a variety
    of services related to intellectual property, announced the launch of an equity
    index that taps the patent asset wellspring.  Priced and published by the American Stock Exchange®, the Ocean Tomo
    300® Patent Index
    (symbol: OTPAT) is the first equity index of its kind.  The index consists of 300 diverse companies
    (six companies within each of fifty size and style groups) selected using Ocean
    Tomo's proprietary PatentRatings® valuation software.

    Ocean Tomo
    In recent press releases, Ocean Tomo announced that,
    since its inception, the Index has enjoyed success.  Its November 30, 2006 press release announced
    that the Index outpaced the Dow Jones Industrial Average and S&P 500 for the
    month of November.  In a December 4, 2006
    press release the company announced that the Index outperformed all the major
    U.S. market indices for the week ending December 1, 2006.  Ocean Tomo also announced in its December 4th
    statement that Claymore Securities has licensed the Ocean Tomo 300® Patent
    Index for a proposed exchange traded fund (ETF).

    It will be interesting to see how this fund progresses
    through its life, and whether investors will continue to invest money in a fund
    based on valuation of intangible assets.

  •     By Jason Derry —

    Thailand Flag
    The public health ministry in Thailand has officially
    announced that it will permit Thailand's public drug maker, the Government Pharmaceutical
    Organization, to manufacture a generic version of Merck's AIDS drug, Efavirenz,
    for a 5 year period.  The compulsory
    license was made by the acting Thai military government, who declared a
    "national emergency" in accordance with World Trade Organization
    requirements relating to government issued compulsory licenses. According to News Target.com, Merck will receive a 0.5% royalty on
    sales of the generic drug.  The decision
    is not without controversy,
    as Merck criticized the Thai government's failure to contact Merck before
    announcing the intent to issue the license.

    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.